The present invention relates to lancets which are lancing devices primarily used to obtain capillary blood samples for various testing purposes, not the least of which is blood glucose in the case of diabetics where such testing may be done on a daily basis. The purpose of the lancet is to penetrate the epidermis to a sufficient depth in order to draw the necessary amount of blood needed for the test, and yet hold the penetration, scaring, and injury to the epidermis to the irreducible minimum.
The present invention has, by way of background, various lancing devices which hold the lancet needle, cover, and carrier. One such device is manufactured for ProCare LLC, and is submitted separately in a prior art disclosure. Basically, however, the lancing device contains a sliding barrel with a trigger button and a base support for the lancet. A lancet cover is provided which threadedly surrounds the lancet as it is positioned in the barrel. At the outer end is an adjustable comfort tip with a lancet cover having numerical indicia and an arrow which, by rotation of the cover, determines the empirical depth to which the needle will penetrate.
Virtually all hypodermic syringes have siliconized needles to aid in insertion to reduce the pain of insertion and further penetration. Therefore, it is desirable to siliconize the lancet needle. This permits the needle to be easily dislodged from the lancet body. In addition, a significant amount of plastic is employed by the prior art for such devices to attempt to secure the needle or blade against dislodgement, and protect against dimensional irregularities.
Therefore, what is needed is a lancet in which the needle portion is firmly embedded in the plastic body, secured against rotation, secured against linear removal, and yet permits the utilization of a minimal amount of plastic, which plastic may be of an inferior grade and therefore less expensive than most lancet bodies, while still providing the sanitary and dimensional support necessary.
The present invention derives from the molding of a lancet body around a needle or blade, in which the inner end of the needle body which is unsharpened has an L-shape bend. As a result of the L-shape bend, when embedded in the plastic which forms the body of the lancet, the needle can neither rotate nor be removed linearly. In short, the needle is permanently immobilized against movement within the body of the lancet, within the X, Y and Z directions. The method of the present invention involves the bending substantially perpendicularly of the unsharpened end of the needle or blade to be substantially perpendicular with the elongate body of the blade. The thus formed needle or blade is placed within a jig interiorly of the plastic mold which is used to form the lancet body and the cover, with the cover surrounding the entirety of the sharpened portion of the needle or blade. The jig includes spaced opposed clamps and a single orienting support to the bent portion of the needle. Also, the body of the lancet is relieved in many areas and has a molded tab cover thereby reducing the plastic used and eliminating a loose part such as a separate cover.
In view of the foregoing it is a principal object of the present invention to provide an apparatus and method for forming a lancet in which the needle or blade is securely positioned against any dislodgement, whether by rotation, or by linear movement within the lancet body.
A further object of the present invention is to provide such a lancet in which rotation and longitudinal dislodgement are prevented, which can accommodate a relatively low grade form of plastic and yet present in operation a dimensionally stable lancet, fully sanitary, for use with the typical user""s home care kit.
A further object of the present invention is addressed to a method of forming a lancet body and needle or blade with a cover head on a highly cost effective basis attributable to the lack of necessity for special purpose jigs to control the position of the needle or blade within the lancet body. As a result, a further objective is achieved by providing the bent leg or L-shaped end portion so that it can be precisely positioned interiorly in the mold, and the plastic body of the lancet molded around the needle or blade with the offset anchor resulting in a product which is dimensionally accurate to tolerances which are acceptable and heretofore unknown on the quantities produced for the disposable lancet market.